Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Injection rituximab: 1) 4 doses of rituximab infusion
375 mg/m2/dose each dose 7 days apart
2) 2 doses of rituximab infusion 375 mg/m2 keeping an interval of 7 days at 6 months
3) 2 dos
Sponsors
Dr Arpita Raychaudhury
Dr Arjun Ray
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with idiopathic nephrotic syndrome with steroid dependence or frequent relapses who has failed at least one steroid sparing agent. 2) Secondary steroid resistant nephrotic syndrome with return of steroid sensitivity during treatment of relapse,failing at leat one immunosuppressant other than steroid. 3) In remission state or 24 hr urine protein 4) Those who have given informed written consent
Exclusion criteria
Exclusion criteria: 1) Primary steroid resistant nephrotic syndrome 2) Secondary cause of nephrotic syndrome 3) Genetic cause of nephrotic syndrome 4) Hepatitis B and C serology positive 5) Acute or chronic active infection 6) Chronic lung disease or uncontrolled asthma 7) Leucopenia or thrombocytopenia 8) ALT/AST >2.5 times upper limit of normal 9) Expected rituximab first infusion date less than 4 weeks from a live vaccination 10) Regular follow-up not feasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To determine the superiority of maintenance over on-demand rituximab in respect to increase in median time to first relapse in difficult to treat childhood onset idiopathic nephrotic syndrome who has failed at least one steroid sparing agent 2.Proportion of patients in relapse in both the arms at the end of the studyTimepoint: Over a period of 1 year 6 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare in the two groups the proportion of patients and the number of days in sustained remission(Relapse free period) 2.To compare in the two groups the frequency of relapses 4.To compare in the two groups the cumulative prednisolone requirement 5.To compare in the two groups the proportion of patients free of corticosteroids 6.To compare the side effects profile of corticosteroids in two arm 7.To compare the nature of tacrolimus resistance between two groups 8.To compare the total number of rituximab dosage in two arms 9.To compare the side effect profile of rituximab between two armTimepoint: Over a period of 1 year 6 months follow up | — |
Countries
India
Contacts
Public ContactDr Arjun Ray
IPGME&R & SSKM Hospital
Outcome results
None listed